Evaluation of the Efficacy of OC-02 Nasal Spray on Signs and Symptoms of Dry Eye Disease (the RAINIER Study)

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-14

Study Completion Date

2018-09-20

Brief Summary

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The objective of this study is to evaluate the safety and effectiveness of OC-02 nasal spray compared to placebo on signs and symptoms of dry eye disease (DED).

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Detailed Description

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This was a Phase 2, multicenter, randomized, double-masked, placebo-controlled study designed to evaluate the safety and efficacy of OC-02 Nasal Spray in adult subjects with dry eye disease. Approximately 45 subjects, at least 22 years of age, with a history of dry eye disease and meeting all other study eligibility criteria were planned to be randomized to receive an application of OC-02 or placebo twice daily (BID) for 4 weeks.

Conditions

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Dry Eye Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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OC-02 (simpinicline) spray spray, 11.1 mg/ml

OC-02 (simpinicline) nasal spray, 11.1 mg/ml

Group Type ACTIVE_COMPARATOR

OC-02 (simpinicline) nasal spray

Intervention Type DRUG

OC-02 (simpinicline) nasal spray, 11.1 mg/ml

Placebo

Placebo (vehicle) nasal spray

Group Type PLACEBO_COMPARATOR

Placebo (vehicle) nasal spray

Intervention Type DRUG

Placebo (vehicle) nasal spray

Interventions

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OC-02 (simpinicline) nasal spray

OC-02 (simpinicline) nasal spray, 11.1 mg/ml

Intervention Type DRUG

Placebo (vehicle) nasal spray

Intervention Type DRUG

Other Intervention Names

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OC-02 (simpinicline) nasal spray, 11.1 mg/ml

Eligibility Criteria

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Inclusion Criteria

* Have used and/or desired to use an artificial tear substitute for dry eye symptoms within 60 days prior to Visit 1

Exclusion Criteria

* Have had any intraocular surgery (such as cataract surgery), extraocular surgery (such as blepharoplasty) in either eye within three months or refractive surgery (e.g. laser epithelial keratomileusis, laser-assisted in-situ keratomileusis, photorefractive keratectomy or corneal implant) within twelve months of Visit 1
* Have a history or presence of any ocular disorder or condition in either eye that would, in the opinion of the Investigator, likely interfere with the interpretation of the study results or participant safety such as significant corneal or conjunctival scarring; pterygium or nodular pinguecula; current ocular infection, conjunctivitis, or inflammation not associated with dry eye; anterior (epithelial) basement membrane corneal dystrophy or other clinically significant corneal dystrophy or degeneration; ocular herpetic infection; evidence of keratoconus; etc. Blepharitis not requiring treatment and mild meibomian gland disease that are typically associated with dry eye disease are allowed.
* Have a systemic condition or disease not stabilized or judged by the Investigator to be incompatible with participation in the study or with the lengthier assessments required by the study (e.g., current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, history of myocardial infarction or heart disease, etc.)
* Have a known hypersensitivity to any of the procedural agents or study drug components
* Have any condition or history that, in the opinion of the investigator, may interfere with study compliance, outcome measures, safety parameters, and/or the general medical condition of the subject

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No